Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, Melbourne, Australia.
J Clin Psychiatry. 2013 Apr;74(4):349-56. doi: 10.4088/JCP.12m07785. Epub 2012 Nov 27.
The ultra-high risk clinical phenotype is associated with substantial distress and functional impairment and confers a greatly enhanced risk for transition to full-threshold psychosis. A range of interventions aimed at relieving current symptoms and functional impairment and reducing the risk of transition to psychosis has shown promising results, but the optimal type and sequence of intervention remain to be established. The aim of this study was to determine which intervention was most effective at preventing transition to psychosis: cognitive therapy plus low-dose risperidone, cognitive therapy plus placebo, or supportive therapy plus placebo.
A double-blind, randomized, placebo-controlled 12-month trial of low-dose risperidone, cognitive therapy, or supportive therapy was conducted in a cohort of 115 clients of the Personal Assessment and Crisis Evaluation Clinic, a specialized service for young people at ultra-high risk of psychosis located in Melbourne, Australia. Recruitment commenced in August 2000 and ended in May 2006. The primary outcome measure was transition to full-threshold psychosis, defined a priori as frank psychotic symptoms occurring at least daily for 1 week or more and assessed using the Comprehensive Assessment of At-Risk Mental States. Secondary outcome measures were psychiatric symptoms, psychosocial functioning, and quality of life.
The estimated 12-month transition rates were as follows: cognitive therapy + risperidone, 10.7%; cognitive therapy + placebo, 9.6%; and supportive therapy + placebo, 21.8%. While there were no statistically significant differences between the 3 groups in transition rates (log-rank test P = .60), all 3 groups improved substantially during the trial, particularly in terms of negative symptoms and overall functioning.
The lower than expected, essentially equivalent transition rates in all 3 groups fail to provide support for the first-line use of antipsychotic medications in patients at ultra-high risk of psychosis, and an initial approach with supportive therapy is likely to be effective and carries fewer risks.
超高危临床表型与显著的痛苦和功能障碍相关，并极大地增加了向全面精神病阈值过渡的风险。一系列旨在缓解当前症状和功能障碍并降低精神病过渡风险的干预措施已经显示出有希望的结果，但最佳的干预类型和顺序仍有待确定。本研究的目的是确定哪种干预措施最能有效预防精神病过渡：认知疗法加低剂量利培酮、认知疗法加安慰剂或支持性治疗加安慰剂。
在澳大利亚墨尔本的个人评估和危机评估诊所，对超高危精神病风险的 115 名患者进行了为期 12 个月的双盲、随机、安慰剂对照的低剂量利培酮、认知疗法或支持性治疗试验。招募工作于 2000 年 8 月开始，2006 年 5 月结束。主要结局指标是过渡到全面精神病阈值，定义为至少每天出现 1 周或更长时间的明显精神病症状，并使用风险精神状态综合评估进行评估。次要结局指标为精神病症状、社会心理功能和生活质量。
估计的 12 个月过渡率如下：认知疗法+利培酮，10.7%；认知疗法+安慰剂，9.6%；支持性治疗+安慰剂，21.8%。虽然三组的过渡率之间没有统计学上的显著差异（对数秩检验 P=.60），但所有三组在试验中都有了实质性的改善，特别是在阴性症状和总体功能方面。
三组的过渡率低于预期，基本相等，这不能为超高危精神病患者一线使用抗精神病药物提供支持，支持性治疗的初始方法可能是有效的，且风险较小。
